The FDA's Medical Device Cybersecurity Overhaul Has Real Teeth, Experts Say
The physical and cyber safety issues surrounding medical devices like IV pumps is finally being meaningfully addressed by a new policy taking effect this week.
Stay updated with the latest healthcare cybersecurity trends, news, and tips to protect patient data and comply with medical industry security standards.
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Background for this topic.
Healthcare is the delivery of clinical care and related services through hospitals, clinics, laboratories, pharmacies, insurers, and connected medical devices. It depends on electronic health records (EHRs), patient identity systems, diagnostic and imaging platforms, medication and scheduling systems, and data exchanges between organizations. These environments hold sensitive health and payment information, while the availability and integrity of systems can affect treatment, diagnostics, and patient safety.
Security concerns include unauthorized access or disclosure of records, alteration of clinical data, and disruption of care through attacks on EHRs, connected devices, or third-party services. Defenses require risk-based access controls, strong authentication, network separation where appropriate, secure device and software maintenance, backups that support clinical continuity, and tested downtime and incident-response procedures. Vulnerability management must account for legacy systems and devices that cannot be patched quickly. Privacy and compliance obligations, such as HIPAA in the United States, shape how organizations collect, use, share, retain, and report health information.
The physical and cyber safety issues surrounding medical devices like IV pumps is finally being meaningfully addressed by a new policy taking effect this week.
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New medical devices applications should "monitor, identify, and address" cybersecurity issues
In addition to $100k given to LockBit New York law firm Heidell, Pittoni, Murphy and Bach (HPMB) has agreed to pay $200,000 to settle a data-breach lawsuit related to the now-notorious Hafnium Microsoft Exchange attacks that siphoned sensitive data from victims around the world. …